COVID-19 vaccine capacity: Challenges and mitigation – The DCVMN perspective

Vaccine manufacturers from developing countries have a proven track record of developing, producing, and supplying high-quality vaccines globally. However, due to the complexity of vaccine manufacturing, numerous stakeholder organizations support manufacturers across a variety of functions. To optimize the support from stakeholders it is instrumental to first understand which manufacturing processes these manufacturers require support for and what support functions are most beneficial. To this end, the Developing Countries Vaccine Manufacturers Network designed a comprehensive survey to assess the specific needs of the Network’s member organizations.We found that almost all sampled manufacturers are interested in obtaining funding or technology transfers for COVID-19 vaccines. Furthermore, results indicated that manufacturers have a strong appetite for modern technology platforms, particularly RNA technologies. Scale-up, phase III clinical trials, and formulation were also key processes for which manufacturers require support.     

Seropositivity to Nucleoprotein to detect mild and asymptomatic SARS-CoV-2 infections: A complementary tool to detect breakthrough infections after COVID-19 vaccination?

BackgroundWith COVID-19 vaccine roll-out ongoing in many countries globally, monitoring of breakthrough infections is of great importance. Antibodies persist in the blood after a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Since COVID-19 vaccines induce immune response to the Spike protein of the virus, which is the main serosurveillance target to date, alternative targets should be explored to distinguish infection from vaccination.MethodsMultiplex immunoassay data from 1,513 SARS-CoV-2 RT-qPCR-tested individuals (352 positive and 1,161 negative) without COVID-19 vaccination history were used to determine the accuracy of Nucleoprotein-specific immunoglobulin G (IgG) in detecting past SARS-CoV-2 infection. We also described Spike S1 and Nucleoprotein-specific IgG responses in 230 COVID-19 vaccinated individuals (Pfizer/BioNTech).ResultsThe sensitivity of Nucleoprotein seropositivity was 85% (95% confidence interval: 80–90%) for mild COVID-19 in the first two months following symptom onset. Sensitivity was lower in asymptomatic individuals (67%, 50–81%). Participants who had experienced a SARS-CoV-2 infection up to 11 months preceding vaccination, as assessed by Spike S1 seropositivity or RT-qPCR, produced 2.7-fold higher median levels of IgG to Spike S1 ≥ 14 days after the first dose as compared to those unexposed to SARS-CoV-2 at ≥ 7 days after the second dose (p = 0.011). Nucleoprotein-specific IgG concentrations were not affected by vaccination in infection-naïve participants.ConclusionsSerological responses to Nucleoprotein may prove helpful in identifying SARS-CoV-2 infections after vaccination. Furthermore, it can help interpret IgG to Spike S1 after COVID-19 vaccination as particularly high responses shortly after vaccination could be explained by prior exposure history.     

SARS-CoV-2 vaccine breakthrough infections in Virginia,January 17, 2021 – June 30, 2021

As COVID-19 vaccines moved from the controlled environment of clinical trials to use in real-world settings, it has been important to evaluate vaccine effectiveness. A retrospective cohort study was designed to identify cases of SARS-CoV-2 infection that occurred between January 17-June 30, 2021 in fully vaccinated Virginia residents. Of the fully vaccinated population of Virginia at the end of the study period (N = 4,271,505), 2445 (0.057 %) were reported to have experienced a vaccine breakthrough infection. Of those, 183 (7.5 %) were reported to have been hospitalized for COVID-19 and 53 (2.2 %) died from COVID-19. There were significant differences in vaccine effectiveness over time between both mRNA vaccines and the Janssen vaccine. Increasing age, pre-existing medical conditions, and male sex were associated with severe outcomes (hospitalization or death). Persons at greater risk for severe outcomes should continue to take precautions to prevent SARS-CoV-2 infection, even if fully vaccinated.     

COVID-19 vaccine and boosted immunity: Nothing ad interim to do?

Today, Coronavirus Disease 2019 (COVID-19) is a global public health emergency and vaccination measures to counter its diffusion are deemed necessary. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the etiological agent of the disease, unleashes a T-helper 2 immune response in those patients requiring intensive care. Here, we illustrate the immunological mechanism to train the immune system towards a more effective and less symptomatic T-helper 1 immune response, to be exploited against SARS-CoV-2.     

Nursing Homes and Long Term Care After COVID-19: A New ERA?

The journal of nutrition, health & aging -     

COVID-19 vaccine reactogenicity – A cohort event monitoring study in the Netherlands using patient reported outcomes

ObjectivesTo explore factors that are associated with reactogenicity in general and systemic after the first dose of COVID-19 vaccine in the Netherlands.DesignA web-based prospective cohort design using patient reported outcomes (PROs).SettingAny person who has been vaccinated with any brand of COVID-19 vaccine in the Dutch COVID immunization programme.Participants22,184 participants. Of these, 13,959 (62.9%) experienced reactogenicity in general and 11,979 (54.0%) systemic reactogenicity within 7 days after vaccination.Main outcome measuresFactors that are associated with the occurrence of reactogenicity after COVID-19 vaccination.ResultsCompared to the Comirnaty® vaccine, the highest odds ratio (OR) for developing reactogenicity was for the Vaxzevria® vaccine (OR 5.18) followed by Spikevax® (OR 2.16), and Janssen (OR 1.65). Participants with a history of COVID-19 disease had a 3.10 increased odds for reactogenicity. Women had a 2.08 increased odds compared to men. Older participants experienced less reactogenicity. Compared to the age group < 50, the ORs for the age groups 50–60, 61–79, and ≥80 were 0.36, 0.15, and 0.10 respectively. The use of an antipyretic drug, or a drug for nervous system disorders gave an increased odds of 1.34 and 1.16 respectively. A body mass index of 25.0–29.9 and over 30 was negatively associated with reactogenicity (OR 0.87 and OR 0.72 respectively). Comorbidities that were associated with reactogenicity were cardiac disorders (OR 1.26), respiratory disorders (OR 1.31), psychiatric disorders (1.37), reproductive disorders (OR 1.54), and eye disorders (OR 1.55). The factors associated with systemic reactogenicity were mostly comparable, but there were differences for comorbidities, drug use, and the strength of the regression coefficient.ConclusionsThis extensive study with over 22,000 vaccine recipients in the Netherlands demonstrated that, taken into account all factors in the model, the Comirnaty® vaccine gave the least and the Vaxzevria® vaccine the most reactogenicity in general and systemic after the first dose. Also a person with a history of COVID-19 disease, female sex and younger age had an increased odds for experiencing reactogenicity after vaccination.     

Myocarditis following COVID-19 vaccination – A case series

There have been reports of myocarditis following COVID-19 vaccination. We surveyed all hospitalized military personnel in the Isareli Defense Forces during the period of the COVID-19 vaccination operation (12/28/2021–3/7/2021) for diagnosed myocarditis. We identified 7 cases of myocarditis with symptoms starting in the first week after the second dose of COVID-19 Pfizer-BioNTech vaccine. One case of myocarditis diagnosed 10 days after the second dose of the vaccine was not included. These 8 cases comprise of all events of myocarditis diagnosed in military personnel during this time period. All patients were young and generally healthy. All had mild disease with no sequalae. The incidence of myocarditis in the week following a second dose of the vaccine was 5.07/100,000 people vaccinated. Due to the nature of this report no causality could be established. Clinicians should be aware of the possibility of myocarditis following Pfizer-BioNTech vaccination. True incidence rates should be further investigated.     

Is vaccine confidence an unexpected victim of the COVID-19 pandemic?

Vaccines are among the safest and most effective primary prevention measures. Thanks to the synergistic global efforts of research institutions, pharmaceutical companies and national health services, COVID-19 vaccination campaigns were successfully rolled out less than a year after the start of the pandemic. While the unprecedented speed of development and approval of COVID-19 vaccines has been applauded as a public health success story, it also spurred considerable controversy and hesitancy even amongst individuals that did not previously hold anti-vaccination stances. This study aimed to compare pre- and post-pandemic vaccine confidence trends in different demographic groups by analysing the outcomes of two online surveys run respectively in November 2019 and January 2022 involving a total of 1009 participants.Non-parametric tests highlighted a statistically significant decline in vaccine confidence in the 2022 cohort compared to the 2019 cohort, with median Vaccine Confidence Score dropping from 22 to 20 and 23.8% of participants reporting that their confidence in vaccines had declined since the onset of the pandemic. While the majority of internal trends were comparable between the two surveys with regards to gender, graduate status and religious belief, vaccine confidence patterns showed considerable alterations with regards to age and ethnicity. Middle-aged participants were considerably more hesitant than younger groups in the 2019 cohort, however this was not the case in the 2022 survey. In both surveys White participants showed significantly higher vaccine confidence than those from Black backgrounds; in the 2022 cohort, unlike the pre-pandemic group, Asian participants showed significantly lower confidence than White ones.This study suggests that paradoxically, despite the success of COVID-19 vaccination campaigns, vaccine confidence has significantly declined since the onset of the pandemic; the comparison of a pre- and post-pandemic cohort sheds light on the differential effect that the pandemic had on vaccine confidence in different demographic groups.     

How do COVID-19 vaccine mandates affect attitudes toward the vaccine and participation in mandate-affected activities? Evidence from the United States

The spread of COVID-19 has prompted many governments, schools, and companies to institute vaccine mandates. Proponents suggest that mandates will enhance public health and increase vaccination rates. Critics suggest that evidence of mandates’ effectiveness is unclear and warn that mandates risk increasing societal inequalities if unvaccinated minority groups opt out of educational, commercial, and social activities where mandates are required. We conduct an original survey experiment on a nationally representative sample of 1,245 Americans to examine the efficacy and effect of COVID-19 mandates. Our findings suggest that mandates are unlikely to change vaccination behavior overall. Further, they may increase the likelihood that sizable percentages of the population opt out of activities where vaccines are mandated. We conclude that mandates that do go into effect should be accompanied by persuasive communications targeted to specific information needs and identities.     

Did the European suspension of the AstraZeneca vaccine decrease vaccine acceptance during the COVID-19 pandemic?

On March 11, 2021, the AstraZeneca vaccine against COVID-19 was suspended in three Nordic countries and, on subsequent days, in other European countries. Using data on vaccine acceptance in eight Western countries obtained on a daily basis, we show that these decisions - and associated news - decreased public vaccine acceptance in several countries and part of this decrease happened in response to suspensions in other countries. The findings demonstrate the importance of international coordination between health authorities during a pandemic such that local authorities are able to put the decisions of foreign authorities into perspective.     

Does a major change to a COVID-19 vaccine program alter vaccine intention? A qualitative investigation

BackgroundOn 8th April 2021, the Australian Technical Advisory Group on Immunisation (ATAGI) made the Pfizer-BioNtech (Comirnaty) vaccine the “preferred” vaccine for adults in Australia aged < 50 years due to a risk of thrombosis with thrombocytopenia syndrome (TTS) following AstraZeneca vaccination. We sought to understand whether this impacted COVID-19 vaccine intentions.MethodWe undertook qualitative interviews from February – April 2021 before and after the program change with 28 adults in Perth, Western Australia. Using our COVID-19 vaccine intentions model, we assessed changes in participants’ COVID-19 vaccine intention before and after the program change. Participants were classified as 1) ‘acceptors’: no concerns about COVID-19 vaccine safety, efficacy, access and would accept whatever vaccine is offered, 2) ‘cautious acceptors’: some concerns and would prefer a particular vaccine brand but would accept whatever is offered, 3) ‘Wait awhile’: for more data, easier access, for another vaccine brand, a greater perceived COVID-19 threat or until mandatory, or 4) ‘refuser’: no intention to vaccinate due to concerns about safety and/or efficacy.ResultsBefore the change, 7/18 of those aged < 50 years were ‘acceptors,’ 10/18 were ‘cautious acceptors’ and 1/18 was ‘wait awhile.’ Overall, 14/18 participants had the same COVID-19 vaccine intention after the change; 4/18 became more concerned. For those aged ≥ 50 years and before the change, 5/10 were ‘acceptors’ and 5/10 were ‘cautious acceptors.’ After the change, 8/10 still had the same COVID-19 vaccine intention; 2/10 became more cautious. The major concern before the program change was COVID-19 vaccines having different vaccine efficacy; the concern pivoted to safety.ConclusionThe majority of participants were ‘cautious acceptors’ who intended on being vaccinated; many had this intention before and after the program change. The Australian government, health care providers and media need to better address COVID-19 vaccine concerns to assist those with COVID-19 vaccine intentions receive a vaccine.